Phase 3
N=183
Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial
Thyroidectomy
Bottom Line
View on ClinicalTrials.gov: NCT00472446 ↗Enrolled (actual)
183
Serious AEs
0.6%
Results posted
Sep 2016
Primary outcome: Primary: Post-operative Pain Measured by Visual Analogue Scale — 2.15; 2.02; 2.84; 2.72 units on a scale — p=.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- bilateral superficial cervical block (Drug); placebo bilateral superficial cervical block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cantonal Hospital of St. Gallen
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain Measured by Visual Analogue Scale |
1.95; 1.51; 2.20; 2.06 | — |
| PRIMARY Pooled Relative Treatment Effect of VAS |
0.47; 0.45; 0.55; 0.54 | 0.016 sig |
| SECONDARY Post-operative Pain Measured by Visual Analogue Scale |
1.95; 1.51; 2.20; 2.06 | — |
| SECONDARY Consumption of Post-operative Analgetics |
21; 23; 18; 24; 6; 7 | 0.94 |
| SECONDARY Mean Consumption of Post-operative Analgetics |
3.33; 3.37; 4.06; 4.33; 1.25; .93 | 0.328 |
| SECONDARY Hospital Stay |
1.8; 1.6; 2.0; 1.6 | 0.925 |
Summary
The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).
The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.
Eligibility Criteria
Inclusion Criteria
- Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
- Informed consent
Exclusion Criteria
- Intolerance to used medication
- Recurrent disease
- Neck dissection, sternotomy
- Emergency surgery
Data sourced from ClinicalTrials.gov (NCT00472446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.